Condition category
Pregnancy and Childbirth
Date applied
05/12/2002
Date assigned
05/12/2002
Last edited
10/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Judith Lumley

ORCID ID

Contact details

Director
Centre for the Study of Mothers' and Children's Health
La Trobe University
251 Faraday Street
Carlton
VIC 3053
Australia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Research Ethics Number (La Trobe University): 96/97

Study information

Scientific title

Acronym

ABFAB (Attachment to the Breast and Family Attitudes to Breastfeeding)

Study hypothesis

1. That a class specifically focused on the practical aspects of breastfeeding, conducted in the middle of pregnancy, will increase both breastfeeding initiation rates and duration.
2. That two classes specifically focused on family and societal attitudes to breastfeeding, including a partner or significant other, conducted in the middle of pregnancy, will increase both breastfeeding initiation rates and duration.

Ethics approval

Approval was received from:
1. Research and Ethics Committee, Royal Women's Hospital (project number 97/25)
2. Human Ethics Committee, La Trobe University (reference number 96/97)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

Breastfeeding initiation and duration

Intervention

Women were approached at 18-20 weeks of pregnancy and invited to participate in the study. Participants were randomly allocated to a control group or one of two group interventions. Both group interventions took place at 20-25 weeks. Women in all groups had access to the usual childbirth education classes.

1. Practical skills class: A 1.5 hour class mid-pregnancy, focusing on breastfeeding skills, including positioning of the baby and attachment to the breast. This utilised a previously designed and trialled tool, and was for women only.

2. Family attitudes class: Two one hour breastfeeding classes mid-pregnancy, exploring attitudes towards breastfeeding and family attitudes to breastfeeding. This was developed and piloted by the investigators in conjunction with the group facilitators, prior to trial commencement.
Partners/others could attend also.

3. Standard care (control group)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The principal outcomes of the study are the initiation and duration of breastfeeding in the first six months after the birth.

Secondary outcome measures

Exploration of what factors might affect the duration of breastfeeding.

Overall trial start date

01/03/1999

Overall trial end date

31/12/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primiparous
2. English-speaking
3. Less than 24 weeks gestation at recruitment
4. Attending Royal Women's Hospital, Melbourne
5. Not attending Family Birth Centre
6. Public patient

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

972

Participant exclusion criteria

1. Physical problems which prevent women from breastfeeding, such as certain types of breast surgery
2. Choosing either private or birth centre care

Recruitment start date

01/03/1999

Recruitment end date

31/12/2002

Locations

Countries of recruitment

Australia

Trial participating centre

Director
Carlton
VIC 3053
Australia

Sponsor information

Organisation

La Trobe University (Australia)

Sponsor details

Faculty of Health Sciences
Melbourne
VIC 3086
Australia
+61 (0)3 9479 3583
lhs@latrobe.edu.au

Sponsor type

University/education

Website

http://www.latrobe.edu.au/health/healthsci_schoolcent.html

Funders

Funder type

Research council

Funder name

National Health and Medical Research Council (NHMRC, Australia): research grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Royal Women's Hospital, Melbourne: PhD Scholarship

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

VicHealth (Victorian Health Promotion Foundation): PhD Scholarship

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Study protocol: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12946279

Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17456243

Publication citations

  1. Results

    Amir LH, Forster DA, Lumley J, McLachlan H, A descriptive study of mastitis in Australian breastfeeding women: incidence and determinants., BMC Public Health, 2007, 7, 62, doi: 10.1186/1471-2458-7-62.

  2. Forster D, McLachlan H, Lumley J, Beanland C, Waldenström U, Harris H, Earl D, Dyson K, ABFAB. Attachment to the breast and family attitudes to breastfeeding. The effect of breastfeeding education in the middle of pregnancy on the initiation and duration of breastfeeding: a randomised controlled trial [ISRCTN21556494]., BMC Pregnancy Childbirth, 2003, 3, 1, 5, doi: 10.1186/1471-2393-3-5.

Additional files

Editorial Notes